FDA 510(k)

レザスコープ RS-01/B

K番号: K201113 · 2020-12-21

決定日2020-12-21

製品コードHRX

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

Resascope RS-01/B is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Systems Group Srl. It received FDA 510(k) clearance on 2020-12-21 under 510(k) number K201113. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Resascope RS-01/B?

Resascope RS-01/B is a medical device that received FDA 510(k) clearance on 2020-12-21. The listed applicant is Advanced Medical Systems Group Srl. The 510(k) number is K201113.

When did Resascope RS-01/B receive FDA 510(k) clearance?

Resascope RS-01/B received FDA 510(k) clearance on 2020-12-21, under 510(k) number K201113.

Who is the listed applicant for Resascope RS-01/B?

The FDA 510(k) record lists Advanced Medical Systems Group Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resascope RS-01/B?

The FDA product code for Resascope RS-01/B is HRX.

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レザスコープ RS-01/B

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：HRX）

公式ソース